Role Summary The DHF Remediation Engineer will be responsible for reviewing, assessing, remediating, and updating Design

History Files (DHF) and Design Control documentation for medical devices to ensure compliance with EU MDR

2017/745, ISO 13485, ISO 14971, and FDA Design Control requirements. The role requires strong expertise in design controls, risk management, traceability, verification and validation documentation, technical file remediation, and cross-functional collaboration with R&D;, Regulatory Affairs, Quality, and Clinical teams.

Mandatory Skills -

- DHF Remediation
- Design Controls
- Technical Documentation Review
- Requirements Traceability
- Verification & Validation Documentation
- Root Cause Analysis
- Medical Device Product Development Lifecycle

Key Responsibilities

DHF Assessment & Remediation
- Perform detailed gap assessments of legacy and active DHF documentation.
- Review and remediate:

- User Needs
- Intended Use Statements
- Product Requirements
- Design Inputs
- Design Outputs
- Design Review Records
- Design Verification Reports
- Design Validation Reports
- Design Transfer Documentation
- Traceability Matrices

• Ensure completeness and consistency of design control records across the product lifecycle.

Design Control Activities

- Support remediation activities in accordance with Design Control requirements.
- Ensure traceability between:

- User Needs

- Design Inputs

- Design Outputs

- Risk Controls

- Verification Evidence

- Validation Evidence

• Support design review meetings and remediation closure activities.

Risk Management Basic understanding

- Develop and update:

- Risk Management Plans
- Hazard Analysis
- DFMEA
- Use FMEA
- Risk Assessment Reports
- Benefit-Risk Documentation

• Ensure alignment with ISO 14971 requirements. Verification & Validation Support
- Author and review:

- Verification Protocols
- Verification Reports
- Validation Protocols
- Validation Reports
- Test Method Validation Documents

• Review evidence supporting product safety,



performance, and compliance.
- Support reliability, functional, environmental, and performance testing activities.

EU MDR Technical Documentation Support
- Support Technical File remediation activities.
- Contribute to Annex II and Annex III documentation updates.
- Assist with:

- Clinical Evaluation inputs
- PMS documentation review
- PMCF documentation support
- Labeling and IFU remediation

• Support Notified Body observations and remediation responses.

Technical Competencies

Mandatory Skills

- DHF Remediation
- Design Controls
- Technical Documentation Review
- Requirements Traceability
- Verification & Validation Documentation
- Root Cause Analysis
- Medical Device Product Development Lifecycle

Regulatory Knowledge

Robust working knowledge of

- EU MDR 2017/745
- ISO 13485:2016
- ISO 14971
- FDA 21 CFR Part 820 / QMSR
- IEC 62366
- IEC 60601 Series
- Design Control Process Requirements

Tool Knowledge

Preferred experience with

- Windchill PLM, Agile PLM, Teamcenter, TrackWise, Microsoft Office Suite

Preferred Medical Device Experience

Experience with one or more of the following product categories:
- Patient Monitoring Devices
- Ventilators
- Infusion Pumps
- Catheters
- Surgical Devices
- Imaging Systems
- Cardiovascular Devices
- Diagnostic Equipment
- Class II and Class III Medical Devices

Soft Skills

- Excellent technical writing skills
- Strong analytical and problem-solving abilities
- Ability to perform document gap assessments independently
- Effective stakeholder management
- Strong verbal and written communication skills
- Ability to work with global cross-functional teams and regulatory stakeholders.

Ideal Candidate Profile

- 4–12 years of experience in medical device product development, quality engineering, design assurance, or DHF remediation.
- Hands-on experience supporting EU MDR remediation programs.
- Proven expertise in traceability reconstruction, risk file updates, and remediation of Design Control documentation.
- Experience supporting Class II/Class III medical devices is strongly preferred.

📌 Verification And Validation Engineer (Pune)
🏢 Glauben Technologies
📍 Pune